Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Multi-Center Study of GSK2857916 in Combination With Pomalidomide and Dex

This research is looking at a new medicine called GSK2857916, given with two other drugs, pomalidomide and dexamethasone, for adults with multiple myeloma. This is a type of cancer that affects plasma cells in the bone marrow and has either returned (relapsed) or isn't responding to previous treatments (refractory). The study is in two parts. The first part aims to find the best and safest dose of the new drug combination. Once that dose is found, the second part will continue to check how safe and effective it is over a longer period. Participants will receive the new drug through a drip, and the other two medicines as tablets, usually over 28-day cycles.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Canadian Myeloma Research Group

Enrolment target

120

Start

26 Nov 2018

Estimated completion

31 Dec 2026

Relapsed and/or Refractory Multiple Myeloma

What is this study about?

This study is investigating a new treatment approach for multiple myeloma, a type of cancer that affects certain blood cells in your bone marrow. The focus is on people whose myeloma has either returned after previous treatments or isn't responding (relapsed and/or refractory). The new drug, GSK2857916, is being tested in combination with two medicines that are already used for myeloma: pomalidomide and dexamethasone.

The main goal of this research is twofold: firstly, to find the safest and most effective dose of the new drug when given with the others. Scientists call this 'dose-finding'. Once that ideal dose is established, the study will expand to include more participants to continue checking how well it works and if there are any side effects. All participants will know which treatments they are receiving.

Taking part in this study means you would receive the new medicine through a drip (intravenously), while pomalidomide and dexamethasone are given as tablets. These treatments are typically given in cycles, usually lasting 28 days. The treatment will continue for as long as it seems to be helping you.

Key takeaways

It's for adults with multiple myeloma that has returned or isn't responding to treatment.
A new drug is being tested with two existing myeloma medicines.
The study aims to find the safest and most effective dose.
Treatment is given in 28-day cycles, through a drip and as tablets.
You will know which treatments you are receiving.
There's a chance of potential benefit, but also potential risks and side effects.

Who may be eligible?

To join this study, you need to be at least 18 years old and able to understand and agree to the study requirements. You must have been diagnosed with multiple myeloma that has either returned or stopped responding to previous treatments.

Specifically, you should have already had two or more treatments for your myeloma, including medicines like lenalidomide and a proteasome inhibitor. If you've had a stem cell transplant, it must have been over 100 days ago, and you can't have an active infection.

The study also requires that doctors can measure your myeloma, usually through blood or urine tests, to see how the treatment is working. Your general health and ability to carry out daily activities, as assessed by a doctor, are also important factors. Women who could become pregnant and men must agree to use reliable birth control during and for a period after the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have multiple myeloma that has come back or isn't responding to previous treatments?
Have you already received two or more treatments for your myeloma, including lenalidomide and a 'proteasome inhibitor'?
If you've had a stem cell transplant, was it more than 100 days ago?
Can your doctors measure your myeloma through blood or urine tests?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive the new drug (GSK2857916) through a drip into your vein. The other two medicines (pomalidomide and dexamethasone) will be given as tablets you swallow. These treatments are usually given in repeating 28-day cycles. In the first part of the study, the timing of the new drug might vary (once or twice per cycle) as researchers look for the best dose. In the second part, everyone will receive the established dose. You will have regular visits for blood tests, check-ups, and to monitor how you are feeling and how the treatment is affecting your myeloma. The treatment will continue for as long as your doctor believes it is helping you. There will also be follow-up observations after you stop treatment.

Potential risks and benefits

Participating in this study might offer a potential benefit of receiving a new treatment that could help your multiple myeloma when other options haven't worked or are no longer effective. However, as with any medication, there are potential risks of side effects, which the study doctors will explain to you in detail. Your safety will be closely monitored throughout the study. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Cross Cancer Institute
Verified postcode
Edmonton, Canada
Vancouver General Hospital
Verified postcode
Vancouver, Canada
CancerCare Manitoba
Verified postcode
Winnipeg, Canada
QEII Health Sciences Centre
Verified postcode
Halifax, Canada
Juravinski Cancer Centre
Verified postcode
Hamilton, Canada
London Health Sciences Centre
Verified postcode
London, Canada
The Ottawa Hospital
Verified postcode
Ottawa, Canada
Princess Margaret Cancer Centre
Verified postcode
Toronto, Canada
Allan Blair Cancer Centre
Verified postcode
Regina, Canada

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects particular white blood cells, called plasma cells, which are found in your bone marrow.

Why is this study happening?

This study is testing a new drug combination to see if it can be a safe and effective treatment for people whose multiple myeloma has returned or isn't responding to current treatments.

How will I know what treatment I'm getting?

This is an 'open-label' study, which means both you and your doctors will know exactly which medicines you are receiving.

How long will I be in the study?

Your treatment will continue for as long as your doctor observes a benefit. After you stop treatment, there will be follow-up appointments to monitor your health.

What are 'relapsed' and 'refractory' myeloma?

Relapsed means your myeloma has come back after treatment. Refractory means your myeloma hasn't responded to treatment or has progressed during treatment.